RECRUITING

A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The objectives of this study are to evaluate the glycemic efficacy, safety, and tolerability of ersodetug as add-on to standard of care (SOC) therapy for treatment of hypoglycemia in patients with Tumor Hyperinsulinism (Tumor HI).

Official Title

A Phase 3, Single-Arm, Open-label, Pivotal Study to Evaluate the Efficacy and Safety of Ersodetug Compared to Baseline in Patients With Inadequately Controlled Hypoglycemia Due to Tumor Hyperinsulinism (Tumor HI)

Quick Facts

Study Start:2025-04-16

Study Completion:2027-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06881992

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* The eligibility criteria of all participants must be evaluated by a multidisciplinary team led by the PI, which must include an oncologist * Male or female participants of ≥18 years of age who provide written informed consent. * Clinical diagnosis of neuroendocrine tumor (NET) (ICT or NICT) with biochemical evidence of tumor hyperinsulinism (hypoglycemia with inappropriately elevated insulin or insulin-like growth factor (IGF)/variant suppression) confirmed via laboratory assessment who have failed to achieve adequate control of hypoglycemia with usual SOC anti-hypoglycemic therapies, per investigator judgement. * Currently requiring IV glucose infusion and/or parenteral nutrition for ≥7 days for the management of refractory hypoglycemia (prior to administration of the 1st dose of ersodetug).	* Evidence of active infection including human immunodeficiency virus, hepatitis B, or hepatitis C (excluding immunization patterns). * Treatment with an investigational drug or device within 30 days or 5 half-lives of the investigational drug (whichever is longer), however, if the treating physician and Medical Monitor consider no significant risk of drug-drug interaction and potential benefit outweighs the risk then the participant may be allowed to participate. Participation in registries and purely diagnostic studies is allowed * Any out-of-range laboratory value at screening (other than glucose) that is assessed as clinically significant by the investigator. Laboratory or radiographic abnormalities that are considered related to the underlying disease (tumor) or associated therapies and do not pose additional safety risk for study participation per investigator and Medical Monitor may be allowed. * Known allergy or sensitivity to ersodetug or any component of the drug. * Any organ condition, concomitant disease (e.g., psychiatric illness, severe alcoholism, or drug abuse, cardiac, hepatic, or kidney disease), or other abnormality that itself, or the treatment of which in the opinion of the investigator and/or Sponsor's Medical Monitor would pose an unacceptable risk to the participant in the study. * Estimated life expectancy (additional lifespan) due to underlying disease (tumor) is \<8 weeks.

Inclusion Criteria

Exclusion Criteria

* The eligibility criteria of all participants must be evaluated by a multidisciplinary team led by the PI, which must include an oncologist
* Male or female participants of ≥18 years of age who provide written informed consent.
* Clinical diagnosis of neuroendocrine tumor (NET) (ICT or NICT) with biochemical evidence of tumor hyperinsulinism (hypoglycemia with inappropriately elevated insulin or insulin-like growth factor (IGF)/variant suppression) confirmed via laboratory assessment who have failed to achieve adequate control of hypoglycemia with usual SOC anti-hypoglycemic therapies, per investigator judgement.
* Currently requiring IV glucose infusion and/or parenteral nutrition for ≥7 days for the management of refractory hypoglycemia (prior to administration of the 1st dose of ersodetug).

* Evidence of active infection including human immunodeficiency virus, hepatitis B, or hepatitis C (excluding immunization patterns).
* Treatment with an investigational drug or device within 30 days or 5 half-lives of the investigational drug (whichever is longer), however, if the treating physician and Medical Monitor consider no significant risk of drug-drug interaction and potential benefit outweighs the risk then the participant may be allowed to participate. Participation in registries and purely diagnostic studies is allowed
* Any out-of-range laboratory value at screening (other than glucose) that is assessed as clinically significant by the investigator. Laboratory or radiographic abnormalities that are considered related to the underlying disease (tumor) or associated therapies and do not pose additional safety risk for study participation per investigator and Medical Monitor may be allowed.
* Known allergy or sensitivity to ersodetug or any component of the drug.
* Any organ condition, concomitant disease (e.g., psychiatric illness, severe alcoholism, or drug abuse, cardiac, hepatic, or kidney disease), or other abnormality that itself, or the treatment of which in the opinion of the investigator and/or Sponsor's Medical Monitor would pose an unacceptable risk to the participant in the study.
* Estimated life expectancy (additional lifespan) due to underlying disease (tumor) is \<8 weeks.

Contacts and Locations

Study Contact

Rezolute Clinical Trial

CONTACT

650-206-4507

clinicaltrials@rezolutebio.com

Study Locations (Sites)

Investigative Site

Boston, Massachusetts, 02114

United States

Investigative Site

Rochester, Minnesota, 55905

United States

Investigative Site

Canton, Ohio, 44718

United States

Investigative Site

Portland, Oregon, 97239

United States

Collaborators and Investigators

Sponsor: Rezolute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-16

Study Completion Date2027-09

Study Record Updates

Study Start Date2025-04-16

Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

Doege-Potter Syndrome
Ectopic insulinoma
Extra-pancreatic insulinoma
Fibrosarcoma
HCC
Hyperinsulinemia
Hypoglycemia
Hypoglycemia due to fibrosarcoma
Hypoglycemia due to HCC
Hypoglycemia due to liposarcoma
Hypoglycemia due to tumor/cancer
IGF 2 Insulinoma
IGF 2 mediated non islet cell tumor hypoglycemia
IGF-2 mediated hypoglycemia
IGF-2, Big IGF-2
IGF-oma, IGF-2-oma, Big IGF-2-oma
Insulinoma
Islet cell tumor (ICT)
Liposarcoma
Neuroendocrine tumor (NET)
NICTH
Non Islet Cell Tumor
Non-islet cell tumor hypoglycemia (NICTH)
Paraneoplastic
Paraneoplastic hypoglycemia
PNET
Pro-insulinoma
Tumor/cancer associated hypoglycemia
Tumor/cancer induced hypoglycemia
Tumor/cancer mediated hypoglycemia
Clinical Trials for: -Insulinoma -proinsulinoma -extrapancreatic insulinoma -non-islet cell tumor -IGF-oma -HCC -Liposarcoma -Fibrosarcoma

Additional Relevant MeSH Terms

Tumor Hyperinsulinism (Tumor HI)